Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis (VIP-S)
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| ClinicalTrials.gov Identifier: NCT02690701 |
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Recruitment Status :
Completed
First Posted : February 24, 2016
Results First Posted : July 9, 2019
Last Update Posted : January 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Plaque Psoriasis | Drug: Secukinumab 300 mg Biological: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 91 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis |
| Actual Study Start Date : | February 10, 2016 |
| Actual Primary Completion Date : | April 26, 2017 |
| Actual Study Completion Date : | February 19, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Secukinumab
Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 48 inclusive
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Drug: Secukinumab 300 mg
Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive. The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits. The injections not occurring on days of study visits were done by the patients (or caregivers) at home. Other Name: AIN457 300 mg |
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Placebo Comparator: Placebo then Secukinumab
Eligible patients received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Beginning with the Week 12 dose, participants were switched to treatment with secukinumab 300 mg and were dosed once weekly at Weeks 12, 13, 14, 15 and 16 followed by monthly dosing through Week 48 inclusive. |
Biological: Placebo
Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive. The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits. The injections not occurring on days of study visits were done by the patients (or caregivers) at home. |
- Aortic Vascular Inflammation as Measured by FDG-PET/CT [ Time Frame: baseline, 12 weeks ]
Change from baseline in the target to background ratio from the whole aorta.
Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12.
Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)
- Change in Adiponectin Total [ Time Frame: baseline, 12 weeks ]Change from baseline in Adiponectin to measure adiposity
- Change in Apolipoprotein B [ Time Frame: baseline, 12 weeks ]Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
- Change in CRP [ Time Frame: baseline, 12 weeks ]Change from baseline in C reactive protein (CRP), a measure of inflammation
- Change in Cholesterol [ Time Frame: baseline, 12 weeks ]Change from baseline in Cholesterol level
- Change in Fetuin A [ Time Frame: baseline, 12 weeks ]Change from baseline in Fetuin A, a marker predictive of diabetes
- Change in Ferritin [ Time Frame: baseline, 12 weeks ]Change from baseline in Ferritin, a marker predictive of diabetes
- Change in GlycA [ Time Frame: baseline, 12 weeks ]Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
- Change in HDL Cholesterol [ Time Frame: baseline, 12 weeks ]Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
- Change in HDL Function (Cholesterol Efflux) [ Time Frame: baseline, 12 weeks ]
Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker
Ratio of the pleated serum to removal of Cholesterol
- HDL Particle Total [ Time Frame: baseline, 12 weeks ]Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
- HDL Size [ Time Frame: baseline, 12 weeks ]Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
- HOMA-IR [ Time Frame: baseline, 12 weeks ]Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR
- Change in IL-2 Receptor A [ Time Frame: baseline, 12 weeks ]Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
- Change in IL-18 [ Time Frame: baseline, 12 weeks ]Interleukin-18 (IL-18) is a marker predictive of diabetes
- Change in IL-6 [ Time Frame: baseline, 12 weeks ]Interleukin 6 (IL-6) is a marker of inflammation
- Change in Intermediate-Density Lipoprotein (IDL) Particle [ Time Frame: baseline, 12 weeks ]Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
- Change LDL Cholesterol [ Time Frame: baseline, 12 weeks ]Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
- Change in Leptin [ Time Frame: baseline, 12 weeks ]Change from baseline in Leptin a marker of adiposity
- LDL Particle Total [ Time Frame: baseline, 12 weeks ]Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
- LDL Size [ Time Frame: baseline, 12 weeks ]Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
- Change in Triglycerides [ Time Frame: baseline, 12 weeks ]Triglycerides are a marker of cardiometabolic function
- Change in TNF-α [ Time Frame: baseline, 12 weeks ]Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha
- Change VLDL Particle Total [ Time Frame: baseline, 12 weeks ]Change in Very-low-density lipoprotein (VLDL) cholesterol level
- VLDL Size [ Time Frame: baseline, 12 weeks ]Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
- Area and Severity Index 75 (PASI 75) [ Time Frame: week 12 ]
Percentage of participants with PASI75 response (yes, no) PASI75 response = at least a 75% improvement (reduction) in PASI score compared to baseline
Psoriasis Area and Severity Index ( PASI) is a tool for measuring the severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
- Psoriasis Area and Severity Index 90 (PASI 90) [ Time Frame: week 12 ]Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90& improvement (reduction) in PASI score compared to baseline
- Psoriasis Area and Severity Index 100 (PASI100) [ Time Frame: week 12 ]Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis
- Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1 [ Time Frame: week 12 ]
percentage of participants with IGA mod 2011 score of 0 or 1 (yes, no)
Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1
Statistical analysis (Cochran-Mantel-Haenszel test) of Novartis Investigator's Global Assessment Modified 2011 0 or 1 response by visit (Non-responder Imputation)
- Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: baseline, 12 weeks ]
Change from baseline in the DLQI total score
Summary of analysis of change from baseline in DLQI at Week 12 and statistical analysis (using Analysis of Covariance) of change from baseline in DLQI at Week 12
The higher the score, the more quality of life is impaired.
0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females at least 18 years of age with moderate to severe plaque psoriasis
Exclusion Criteria:
- Forms of psoriasis other than chronic plaque psoriasis
- Previous exposure to IL-17A or IL-17 receptor targeting agents.
- Other active or ongoing disease that may interfere with evaluation of psoriasis or places the patient at unacceptable risk
- Other protocol-defined inclusion/exclusion criteria may apply
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690701
| United States, California | |
| Novartis Investigative Site | |
| Los Angeles, California, United States, 90033 | |
| Novartis Investigative Site | |
| Santa Ana, California, United States, 92701 | |
| United States, Maryland | |
| Novartis Investigative Site | |
| Rockville, Maryland, United States, 20850 | |
| United States, Missouri | |
| Novartis Investigative Site | |
| Saint Louis, Missouri, United States, 63117 | |
| United States, New York | |
| Novartis Investigative Site | |
| Buffalo, New York, United States, 14221 | |
| Novartis Investigative Site | |
| New York, New York, United States, 10025 1737 | |
| United States, Oregon | |
| Novartis Investigative Site | |
| Portland, Oregon, United States, 97223 | |
| Novartis Investigative Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | |
| Exton, Pennsylvania, United States, 19341 | |
| United States, Texas | |
| Novartis Investigative Site | |
| Dallas, Texas, United States, 75246-1613 | |
| Novartis Investigative Site | |
| Houston, Texas, United States, 77004 | |
| United States, Utah | |
| Novartis Investigative Site | |
| Salt Lake City, Utah, United States, 84132 | |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02690701 |
| Other Study ID Numbers: |
CAIN457AUS02 |
| First Posted: | February 24, 2016 Key Record Dates |
| Results First Posted: | July 9, 2019 |
| Last Update Posted: | January 5, 2021 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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psoriasis plaque psoriasis secukinumab AIN457 |
biologic monoclonal antibody aortic vascular inflammation |
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Psoriasis Inflammation Pathologic Processes Skin Diseases, Papulosquamous Skin Diseases |